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医疗器械助理
9-10K/月北京市-北京/本科及以上/1-3年
张锦云一周前来过
北京艾锐达管理顾问有限公司
职位详情
岗位职责
任职要求：
工作要求：
本科以上学历，有法规事务经验优先、沟通协调能力强、英语熟练
有医疗行业注册经验的优先
岗位职责：
I. NMPA paper document submission and approval letter collection, including Class I filing and IFU filing.
NMPA纸质文件递交和批件领取，包括一类备案和IFU备案等。
II. Consultation appointment of NMPA before product registration acceptance.
产品注册受理前NMPA的咨询预约。
III. Fees for registration items, including registration fee, test fee and translation fee.
注册项目缴费，包括注册费、检测费、翻译费等。
IV. Management of electronic medical device registration certificate, including download, archiving and release.
医疗器械电子注册证的管理，包括下载、存档和发布。
V. Tracking and Statistics of Regulatory Submission and Approval Information.
注册递交和批准信息的追踪和统计。
VI. Lifecycle Archiving of Product Registration Application Dossiers.
产品注册申报资料生命周期存档。
VII. Internal and external account authority management, including NMPA government platform, testing institute, internal system, etc.
内部和外部账户权限管理，包括NMPA政务平台、检测所、内部系统等。
VIII. Responsible for collecting CGUDID data and comprehensively understanding relevant regulatory policies and processes.
收集CGUDID数据，并全面了解法规政策和流程。
IX. Honghui system daily maintenance and data entry check.
红会系统日常维护和数据录入检查。
X. Fully understand the management of relevant Certificates of the Company, and the archive path.
充分了解对公司相关证照及存档路径的管理。
XI. Post Market Compliance: maintain related database accurately; execute routine after-approval processes e.g. Chinese labeling, copy review etc.; timely assess change notification of LCM products, trigger necessary registration activities immediately; support post market actions e.g. audit, inspection, recall…be sensitive on potential regulatory risks.
上市后合规：准确维护相关数据库；执行例行的批准后流程，例如贴中文标签、文案审查等；及时评估LCM产品的变更通知，立即触发必要的注册活动；支持上市后举措，例如审核、检验、召回……对潜在的监管风险保持敏感。
XII. Actively assist in optimizing process operations and the execution of the actions in need. Track and complete the operation of the QMS process as it relates to RA, including JD, SOP/WI. Establish the basic acknowledgement of the QMS and think about the improvements. Find out the pain points in each process documents and share ideas with relevant colleges.
在需要时积极协助优化流程操作和执行需要采取的措施。跟踪并完成与法规事务（RA）相关的质量管理体系（QMS）流程的操作，包括职位说明（JD）、标准操作程序（SOP）/作业指导书（WI）。制定QMS的基础知识并思考相关改进。 找出每个流程文件中的痛点，并与相关同事分享想法。
XIII. Actively support and cooperate the internal and external audit, helping with unexpected issues and problems.
积极支持和配合内部和外部审核工作，帮助解决突发问题。
XIV. Process Excellence: follow company SOP/WI/guidance on routine processes; actively think about improvement & speak out ideas.
流程优化：遵循公司标准操作程序（SOP）/作业指导书（WI）/常规流程指南；积极思考改进并提供思路。
XV. Policy shaping: Curiosity and passion for new regulation, policy, standards and technologies; be familiar with NMPA/CMDE/Lab common working processes; correctly interpret key regulatory requirements by self learning or participating training, preliminarily reflect on impact & implication to projects/business; train WWBU RA & other function members.
政策思维塑造：对新法规、政策、标准和技术怀有好奇心和热情；熟悉NMPA/CMDE/实验室常见工作流程；通过自学或参与培训正确解读关键注册要求，初步反思对项目/业务的影响和启示；培训全球业务部门法规事务部和其他职能部门成员。
XVI. Responsible for daily external Disclosure of Product Common and Confidential Documents and archive the relevant information; think about the main reasons affecting work efficiency.
负责产品通用和机密文件的日常对外披露，并存档相关信息；思考影响工作效率的主要原因。
XVII. Collection and uploading of label information after the approval of Registration Certificate; Support compliance with label template and content.
负责注册证书获批后标签信息的采集与上传；为标签模板和内容合规性方面的工作提供支持。
XVIII. Have in-depth understanding of domestic notarization and foreign affairs certification and relevant procedures.
对国内公证、外事认证及相关程序有深入了解。
XIX. Participate in Advertisement Examination.
参与广告审查。
XX. Have basic knowledge on China BU strategy and market competition of key products.
对中国BU就重点产品的策略和重点产品的市场竞争情况有基本的了解。
XXI. Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for documents & support; communicate with China cross function members on registration status; clearly communicate with reviewers on dossier contents and other external stakeholders (test lab, TC, etc.), influence in certain areas; frequently communicate with supervisor to report progress and escalate risks/issues.
沟通与上报：清晰描述问题/需求，及时向全球业务部门法规事务部索取文件和支持；与中国跨职能团队成员就注册状态进行沟通；与审评员就注册申报资料的内容进行清晰沟通，与其他外部利益攸关方（测试实验室、TC等）进行沟通，在某些领域产生影响；经常与主管沟通，以报告工作进度并上报风险/问题。
XXII. Well practice self management skills, project management, time management, presentation, etc.; good sharing & teaming spirit; actively absorb knowledge from others & trainings; able to take critical role & additional accountabilities for team when needed (e.g. take additional complex projects when there's absence).
有效践行自我管理技能、项目管理、时间管理、演讲宣讲等技能；具有良好的分享和团队精神；积极吸收来自他人传授和从培训中获得的知识；能够在需要时为团队承担关键角色和额外责任（例如：在相关人员缺席时承担额外的复杂项目）。
Other responsibilities defined in written procedures.
流程中规定的其它职责。
工作要求：
本科以上学历，有法规事务经验优先、沟通协调能力强、英语熟练
有医疗行业注册经验的优先
岗位职责：
I. NMPA paper document submission and approval letter collection, including Class I filing and IFU filing.
NMPA纸质文件递交和批件领取，包括一类备案和IFU备案等。
II. Consultation appointment of NMPA before product registration acceptance.
产品注册受理前NMPA的咨询预约。
III. Fees for registration items, including registration fee, test fee and translation fee.
注册项目缴费，包括注册费、检测费、翻译费等。
IV. Management of electronic medical device registration certificate, including download, archiving and release.
医疗器械电子注册证的管理，包括下载、存档和发布。
V. Tracking and Statistics of Regulatory Submission and Approval Information.
注册递交和批准信息的追踪和统计。
VI. Lifecycle Archiving of Product Registration Application Dossiers.
产品注册申报资料生命周期存档。
VII. Internal and external account authority management, including NMPA government platform, testing institute, internal system, etc.
内部和外部账户权限管理，包括NMPA政务平台、检测所、内部系统等。
VIII. Responsible for collecting CGUDID data and comprehensively understanding relevant regulatory policies and processes.
收集CGUDID数据，并全面了解法规政策和流程。
IX. Honghui system daily maintenance and data entry check.
红会系统日常维护和数据录入检查。
X. Fully understand the management of relevant Certificates of the Company, and the archive path.
充分了解对公司相关证照及存档路径的管理。
XI. Post Market Compliance: maintain related database accurately; execute routine after-approval processes e.g. Chinese labeling, copy review etc.; timely assess change notification of LCM products, trigger necessary registration activities immediately; support post market actions e.g. audit, inspection, recall…be sensitive on potential regulatory risks.
上市后合规：准确维护相关数据库；执行例行的批准后流程，例如贴中文标签、文案审查等；及时评估LCM产品的变更通知，立即触发必要的注册活动；支持上市后举措，例如审核、检验、召回……对潜在的监管风险保持敏感。
XII. Actively assist in optimizing process operations and the execution of the actions in need. Track and complete the operation of the QMS process as it relates to RA, including JD, SOP/WI. Establish the basic acknowledgement of the QMS and think about the improvements. Find out the pain points in each process documents and share ideas with relevant colleges.
在需要时积极协助优化流程操作和执行需要采取的措施。跟踪并完成与法规事务（RA）相关的质量管理体系（QMS）流程的操作，包括职位说明（JD）、标准操作程序（SOP）/作业指导书（WI）。制定QMS的基础知识并思考相关改进。 找出每个流程文件中的痛点，并与相关同事分享想法。
XIII. Actively support and cooperate the internal and external audit, helping with unexpected issues and problems.
积极支持和配合内部和外部审核工作，帮助解决突发问题。
XIV. Process Excellence: follow company SOP/WI/guidance on routine processes; actively think about improvement & speak out ideas.
流程优化：遵循公司标准操作程序（SOP）/作业指导书（WI）/常规流程指南；积极思考改进并提供思路。
XV. Policy shaping: Curiosity and passion for new regulation, policy, standards and technologies; be familiar with NMPA/CMDE/Lab common working processes; correctly interpret key regulatory requirements by self learning or participating training, preliminarily reflect on impact & implication to projects/business; train WWBU RA & other function members.
政策思维塑造：对新法规、政策、标准和技术怀有好奇心和热情；熟悉NMPA/CMDE/实验室常见工作流程；通过自学或参与培训正确解读关键注册要求，初步反思对项目/业务的影响和启示；培训全球业务部门法规事务部和其他职能部门成员。
XVI. Responsible for daily external Disclosure of Product Common and Confidential Documents and archive the relevant information; think about the main reasons affecting work efficiency.
负责产品通用和机密文件的日常对外披露，并存档相关信息；思考影响工作效率的主要原因。
XVII. Collection and uploading of label information after the approval of Registration Certificate; Support compliance with label template and content.
负责注册证书获批后标签信息的采集与上传；为标签模板和内容合规性方面的工作提供支持。
XVIII. Have in-depth understanding of domestic notarization and foreign affairs certification and relevant procedures.
对国内公证、外事认证及相关程序有深入了解。
XIX. Participate in Advertisement Examination.
参与广告审查。
XX. Have basic knowledge on China BU strategy and market competition of key products.
对中国BU就重点产品的策略和重点产品的市场竞争情况有基本的了解。
XXI. Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for documents & support; communicate with China cross function members on registration status; clearly communicate with reviewers on dossier contents and other external stakeholders (test lab, TC, etc.), influence in certain areas; frequently communicate with supervisor to report progress and escalate risks/issues.
沟通与上报：清晰描述问题/需求，及时向全球业务部门法规事务部索取文件和支持；与中国跨职能团队成员就注册状态进行沟通；与审评员就注册申报资料的内容进行清晰沟通，与其他外部利益攸关方（测试实验室、TC等）进行沟通，在某些领域产生影响；经常与主管沟通，以报告工作进度并上报风险/问题。
XXII. Well practice self management skills, project management, time management, presentation, etc.; good sharing & teaming spirit; actively absorb knowledge from others & trainings; able to take critical role & additional accountabilities for team when needed (e.g. take additional complex projects when there's absence).
有效践行自我管理技能、项目管理、时间管理、演讲宣讲等技能；具有良好的分享和团队精神；积极吸收来自他人传授和从培训中获得的知识；能够在需要时为团队承担关键角色和额外责任（例如：在相关人员缺席时承担额外的复杂项目）。
Other responsibilities defined in written procedures.
流程中规定的其它职责。
任职要求
无
工作地点
- 朝阳区华贸中心
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公司信息
某医药公司
- 上海
- 10000人以上
- 生物技术
- 外企
- 已上市
强生公司诞生于1886年，经过130多年的发展，如今我们已经是全球最具综合性、业务分布范围广的医疗健康企业之一，业务领域覆盖制药、医疗科技，以及消费者健康领域，在全球约60个国家或地区已经拥有约260家运营公司，全球员工超过14万人。
1985年，强生来到了中国。大家熟知的西安杨森制药有限公司就是强生在华成立的第一家企业。多年来，我们一直致力于提供高质量的创新产品来满足不断增长的医疗健康需求，为中国病患和消费者带来健康，建设健康中国。如今，强生各大业务领域均已进入中国，并分别在该领域成为业界领头羊。2019年，强生中国创新引擎启动。对强生来说，中国不仅仅是重要的市场，也是重要的创新发展助推器。未来，我们将继续扎根中国、投资中国，以强生的百年信条为指引，融合关爱、科学与智慧，为人类健康事业的发展带来意义深远的改变。
